Lucerna Via helps emerging and established neurotherapeutic teams design smarter trials and align development with commercial goals —delivering senior-level expertise without the burden of full-time staff.
Illuminating the Path from Discovery to Impact in Neuroscience
From Science to Strategy
Personalized, High-Impact Partnership
Lucerna Via partners with neuroscience innovators at every stage of development, helping early-stage teams translate strong science into actionable clinical strategies and supporting established companies expanding into neurotherapeutics with focused, evidence-based insight. Every engagement is tailored to your company’s specific challenges and objectives, delivering guidance that is scientifically rigorous, commercially informed, and aligned with regulatory requirements. The result is practical, actionable strategies that move programs efficiently toward approval and market success.
Why Neuroscience Is Different
Clinical development in neuroscience presents unique challenges, from the subjectivity of endpoints and high placebo responses to slow disease progression and patient recruitment hurdles. Lucerna Via brings specialized experience across these complexities, helping teams design feasible, meaningful studies that deliver measurable impact. We understand where biology, behavior, and regulatory science intersect, and apply practical strategies that balance scientific ambition with operational reality.
Science-Driven, Strategy Focused
Lucerna Via bridges deep neuroscience expertise with strategic foresight. We help clients anticipate development challenges, align scientific design with regulatory and commercial goals, and identify data strategies that strengthen clinical and business outcomes. From early concept through pivotal planning, our guidance ensures that every decision is informed by both scientific insight and strategic clarity.
Collaborative Partnership
We see ourselves as an extension of your team. Our role is to listen, adapt, and deliver insights that move your neurotherapeutic development program forward. Whether collaborating on protocol design, strengthening communication plans, or shaping broader clinical strategy, we integrate seamlessly with your workflow to provide the expertise and momentum your program needs.
The Cost of Time in Neurotherapeutic Development
Developing a new neurotherapeutic is a long and complex journey, often taking 12 to 15 years from patent to approval. For early-stage companies, every delay matters. Each added month increases costs, consumes limited runway, and shortens the period of potential market exclusivity. Lucerna Via helps teams anticipate and prevent the bottlenecks that commonly extend timelines. By aligning scientific design with regulatory expectations and operational feasibility, we help clients make informed decisions that preserve both time and value. Our goal is to position programs for steady, efficient progress and generate the kind of evidence that supports success in later development, partnership discussions, and beyond.
Focused on Outcomes
Every project begins with a core question: How will this create meaningful impact?
For us, impact means accelerating innovation, strengthening trial outcomes, and positioning programs for regulatory, investor, and payer confidence. By uniting science with market strategy, we help you maximize resources, mitigate risk, and build a clear path to commercialization—so promising therapies can reach the patients who need them most.
Services
Clinical Trial Strategy
High-level consultation to shape overall trial strategy, ensuring that study designs are scientifically meaningful, strategically differentiated, and aligned with long-term development goals. This includes evaluating where a program fits within the broader clinical and competitive landscape, clarifying objectives that matter most for regulators, payers, and prescribers, and identifying the trial approaches most likely to accelerate adoption. By focusing on positioning and strategy early, we help teams make informed decisions that guide development from first-in-human studies through pivotal trials.
Statistical Planning & Interpretation
Development of statistical analysis plans—in collaboration with seasoned biostatisticians, either from the client’s team or through trusted partners, we provide—to support the design of studies powered to detect endpoints critical for both regulatory approval and commercial adoption. This work is complemented by guidance on data management, interpretation, and outcomes, providing evidence-based insights that support decision-making and strengthen stakeholder confidence.
Protocol Development & Optimization
We integrate feedback from sponsors, key opinion leaders, and regulatory experts to guide the development of protocols that are scientifically rigorous, operationally sound, and strategically aligned. For studies positioned closer to commercialization, we also incorporate payer perspectives to confirm that endpoints and trial design support reimbursement and market access. Our process provides detailed input on protocol structure, inclusion/exclusion criteria, and overall regulatory readiness—helping studies progress not just to advance the pipeline, but to achieve long-term commercial success.
Scientific Communications
We develop clear, compelling scientific communications—from publications and conference presentations to materials for investors and regulators—designed to present your data and strategy with precision and impact.
Early-Stage Development Support
We partner with teams at all stages of development to provide the expertise and execution needed to move projects forward, even when resources are lean. Whether you are generating pre-clinical or early-stage clinical trial data, refining protocols, or preparing investor and regulatory materials, we guide critical activities—such as data analysis, visualization, pitch deck development, and KOL engagement—so they are effective and impactful from the outset. By offering high-level expertise on a flexible basis, we help you achieve your next milestone and build a strong foundation for future growth without the cost of full-time staff.
About Us
Founder & Principal Consultant
Kristen Ade, PhD
Lucerna Via Consulting is led by Dr. Kristen Ade, a neuroscientist with over 20 years of experience in neuroscience and neurology clinical research. She has guided programs across early- and late-stage development, bringing together scientific rigor and strategic clarity to help companies design smarter trials, optimize outcomes, and accelerate innovation.
As Vice President and Chief Scientific Officer at Scion NeuroStim, Kristen directed early phase and pivotal clinical trials of a neuromodulation device for Parkinson’s disease and migraine. In this role, she worked closely with regulators, key opinion leaders, and patient advocacy groups, secured non-dilutive funding from major foundations, and led cross-functional teams to align clinical strategy with regulatory and commercial goals. This experience shaped her ability to bridge science, regulatory pathways, and market strategy—an approach she now applies through Lucerna Via.
Personal Note
My work has always been guided by a commitment to patients, but innovation only reaches them if it successfully navigates the regulatory, reimbursement, and commercial journey. That’s why I take pride in helping biotech teams align trial design with market realities and defining clear paths for promising science to become accessible therapies.
Expertise on demand. Efficiency by design.
A Focused Flexible Approach
Lucerna Via is designed to provide the expertise you need, tailored to your program. While our core services are led directly by Dr. Kristen Ade, we also maintain a trusted network of experienced consultants across clinical trial operations, biostatistics, regulatory affairs, clinical medicine, data management, and other specialized areas.
These collaborators are engaged selectively, based on the unique needs of each project. By working with seasoned independent professionals rather than maintaining a large in-house staff, clients gain senior-level expertise when it’s needed—without the cost or complexity of full-time hires.
This model keeps teams lean, focused, and fully aligned with your goals—delivering high-impact insights and execution without unnecessary overhead.
"What sets Kristen apart is her ability to see the big picture while still driving the details that move programs forward. She bridges science and strategy seamlessly, keeping stakeholders aligned and keeping development efforts centered on delivering treatments to patients."
— ROBERT BLACK, PHD, FORMER CTO &COO OF SCION NEUROSTIM, PRESIDENT OF VEINCARE TECHNOLOGIES
Endorsements
"True medical device breakthroughs are rare, and the difference between success and failure often lies in the design and execution of pivotal clinical studies. Kristen Ade is the most skilled professional I have worked with in designing and conducting such studies. She anticipates challenges, weighs every detail—from inclusion criteria to statistical powering—and ensures studies are both scientifically rigorous and commercially relevant. If there is a role for a new medical technology in clinical practice, Kristen will design and conduct the study to define it, minimizing risk and maximizing the chance of success."
— NAT BOWDITCH, FORMER CEO OF AVANTEC VASCULAR, APNEON, HANCOCK MEDICAL AND ORTHOHUB
"Dr. Ade is exceptional. I had the pleasure of working closely with her for more than five years, and she consistently demonstrated not only intelligence and rigor, but also a deep commitment to collaboration and execution. She brings passion for advancing treatments in neurological disorders and translates that into clear strategies that move programs forward efficiently and with patients always in focus."
— LANTY SMITH, FORMER CEO OF SCION NEUROSTIM, CEO OF TIPPET CAPITAL
Contact us
We offer a complimentary 20-30 minute consultation to learn about your program and discuss your goals.
There’s no obligation- just a chance to explore whether Lucerna Via is the right partner to help move your project forward. Complete the form below, and we will reach out to schedule a consultation at a time that works for you.
This consultation is for informational purposes only and does not establish a client relationship.